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FIT Families Multicomponent Obesity Intervention for African American Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04974554
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : May 9, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Florida State University
Wayne State University
Information provided by (Responsible Party):
Phillipe Cunningham, Medical University of South Carolina

Brief Summary:
Obesity is one of the most prevalent medical problems facing children and adolescents today, particularly among African American adolescents where the rate is alarmingly high. This study will test the effectiveness of FIT Families, a multicomponent family-based behavioral intervention that is culturally tailored to meet the unique needs of African American adolescents with obesity and their caregivers, against a credible attention control condition. This study has considerable public health relevance because it is delivered by Community Health Workers, maximizing the potential for the intervention to be sustained, and may reduce obesity-related health problems for a vulnerable population of adolescents.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Metabolic Syndrome Behavioral: FIT Behavioral: Home-Based Family Support Not Applicable

Detailed Description:
The alarming rates of obesity among children and adults, particularly among ethnic minorities, has been identified by the National Institutes of Health as one of the most serious public health challenges facing our nation in the 21st century. South Carolina (SC), part of the "Stroke Belt," has the 3rd highest obesity rate among US children at 39.2% and the 12th highest obesity rate among US adults at 32.3%. Unfortunately, African Americans in SC are disproportionately more likely to be overweight or obese (75.7% of adults, 40% of children), which places them at considerable high-risk for obesity-related diseases such as asthma, Type 2 diabetes, cardiovascular disease, hypertension, stroke, and some forms of cancer. This public health challenge is compounded by the lack of available intervention strategies specially tailored to meet the unique needs of ethnic minorities. This R01 randomized clinical trial, informed by the results from a recently completed NHLBI/NICHD center grant ("FIT Families Project," U01HL097889; PI-Naar) that followed the National Heart, Lung, and Blood Institute, Obesity Related Behavioral Intervention Trials (ORBIT) model for developing behavioral interventions, will examine the efficacy of FIT Families compared to a credible attention control condition. Each of four evidence-based behavioral components of FIT Families (home-based services, contingency management, motivational interviewing, cognitive behavioral skills training) were culturally tailored and optimized through a proof of concept sequential multiple randomized trial that produced weight loss among African American adolescents, a large and understudied population. One hundred and eighty obese African American adolescents aged 12-17 and their primary caregiver will be randomly assigned to one of two treatment conditions: 1) FIT Families or 2) Home-Based Family Support (HBFS) attention control condition. It is predicted that FIT Families will lead to greater reductions in adolescent and caregiver percent overweight, and increases in physical activity and the use of evidence-based weight management behaviors (self-monitoring of diet and exercise). If effective, FIT Families, which was carefully developed and adapted through successive Phases of ORBIT, has the potential to reduce disparities in obesity-related diseases (cardiovascular and metabolic) by addressing multiple risk factors among African American families and their adolescent children. Thus, this project has high significance in terms of potential public health impact and reduction in obesity related healthcare costs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed study follows a 2 (condition: FIT Families [FIT], and HBFS x 4 (time: baseline [T1], 3-month mid-treatment [T2], 6-month end of treatment [T3], and 12-months follow-up [T4]), with random assignment of 180 caregivers/youths to one of the two treatment conditions. Repeated measures of caregiver and youth percent overweight (primary outcome) and physical activity (secondary outcome) will be collected at baseline (T1), and each of the 3 post-randomization time points (T2-T4).
Masking: Single (Participant)
Masking Description: Study Biostatistician will conduct the randomization of 180 subjects, 90 subjects per condition (FIT vs. HBFS) using a 1:1 allocation ratio. Research Assistants collecting data will be kept blind to participants' randomization status to the extent possible in a behavioral clinical trial.
Primary Purpose: Treatment
Official Title: Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step From the ORBIT Initiative
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : April 30, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FIT Families
1. FIT Families is a 6 month comprehensive multicomponent family-based behavioral intervention delivered by Community Health Workers (CHWs). FIT Families integrates home-based service delivery, Motivational Interviewing (MI; intrinsic motivation), Cognitive Behavior Skills Treatment (CBST; skills acquisition), supervised physical activity (PA), and Contingency Management (CM; extrinsic motivation). Sessions occur twice weekly for the first three months, and weekly for the second three months.
Behavioral: FIT
FIT Families is a home-based intervention that works with youth and caregivers to lose weight and improve their health. The intervention lasts 6 months. Sessions are held twice a week for the first 3 months and then once a week for the second 3 months. These sessions will take place in home with a community health worker. In addition, participants will have the opportunity to earn prizes for completing certain intervention related tasks.

Active Comparator: Home-Based Family Support
2. Home-based Family Support (HBFS). Adolescents and their primary caregiver randomly assigned to HBFS will receive 6 months of weekly, home-based, client-centered, non-directive supportive family counseling.
Behavioral: Home-Based Family Support
Home-Based Family Support Group will receive six months of weekly family counseling in the home. The weekly visits have 3 goals: 1) provide basic education in nutrition and physical recommendations for adolescent and adult obesity; 2) assess and monitor weight, physical activity, and diet via logs; and 3) offer opportunities to discuss barriers they identify to adherence to weight loss recommendations. The HBFS CHW will also address non-weight related problems such as peer or family relationship problems during the visits.




Primary Outcome Measures :
  1. Percent overweight [ Time Frame: Baseline ]
    Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.

  2. Percent overweight [ Time Frame: 3 month mid-treatment ]
    Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.

  3. Percent overweight [ Time Frame: 6 month end of treatment ]
    Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.

  4. Percent overweight [ Time Frame: 12 month follow-up ]
    Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer.

  5. Height [ Time Frame: Baseline ]
    Height in meters will be obtained using a portable stadiometer.

  6. Height [ Time Frame: 3-month mid-treatment ]
    Height in meters will be obtained using a portable stadiometer.

  7. Height [ Time Frame: 6-month end of treatment ]
    Height in meters will be obtained using a portable stadiometer.

  8. Height [ Time Frame: 12-month follow-up ]
    Height in meters will be obtained using a portable stadiometer.

  9. Weight [ Time Frame: Baseline ]
    Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.

  10. Weight [ Time Frame: 3-month mid-treatment ]
    Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.

  11. Weight [ Time Frame: 6-month mid-treatment ]
    Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.

  12. Weight [ Time Frame: 12-month follow-up ]
    Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.


Secondary Outcome Measures :
  1. Percent of body fat [ Time Frame: Baseline ]
    Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

  2. Percent of body fat [ Time Frame: 3-month mid-treatment ]
    Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

  3. Percent of body fat [ Time Frame: 6-month end of treatment ]
    Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

  4. Percent of body fat [ Time Frame: 12-month follow-up ]
    Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

  5. Physical activity [ Time Frame: baseline ]
    Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns

  6. Physical activity [ Time Frame: 3-month mid-treatment ]
    Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns

  7. Physical activity [ Time Frame: 6-month end of treatment ]
    Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns

  8. Physical activity [ Time Frame: 12-month follow-up ]
    Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns

  9. Self-monitoring of physical activity (PA) [ Time Frame: Daily for six months during treatment ]
    Self-Monitoring of PA is assessed using daily diary logbooks completed on line

  10. Self-monitoring of Dietary Intake [ Time Frame: Daily for six months during treatment ]
    Self-Monitoring of Dietary Intake is assessed using daily diary logbooks completed on line

  11. Symptoms of Metabolic Syndrome [ Time Frame: Baseline ]
    Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.

  12. Symptoms of Metabolic Syndrome [ Time Frame: Baseline ]
    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  13. Symptoms of Metabolic Syndrome [ Time Frame: 3-month mid-treatment ]
    Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.

  14. Symptoms of Metabolic Syndrome [ Time Frame: 3-month mid-treatment ]
    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  15. Symptoms of Metabolic Syndrome [ Time Frame: 6-month end of treatment ]
    Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.

  16. Symptoms of Metabolic Syndrome [ Time Frame: 6-month end of treatment ]
    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  17. Symptoms of Metabolic Syndrome [ Time Frame: 12-month follow-up ]
    Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood.

  18. Symptoms of Metabolic Syndrome [ Time Frame: 12-month follow-up ]
    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  19. Hemoglobin A1c (HbA1c) [ Time Frame: Baseline ]
    HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.

  20. Hemoglobin A1c (HbA1c) [ Time Frame: 3-month mid-treatment ]
    HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.

  21. Hemoglobin A1c (HbA1c) [ Time Frame: 6-month end of treatment ]
    HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.

  22. Hemoglobin A1c (HbA1c) [ Time Frame: 12-month follow-up ]
    HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture.

  23. Flanker task [ Time Frame: Baseline ]
    Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.

  24. Flanker task [ Time Frame: 6-month end of treatment ]
    Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.

  25. Flanker task [ Time Frame: 12-month follow-up ]
    Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.

  26. List Sorting test [ Time Frame: Baseline ]
    Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10).

  27. List Sorting test [ Time Frame: 6-month end of treatment ]
    Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10).

  28. List Sorting test [ Time Frame: 12-month follow-up ]
    Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10).

  29. Delayed Reward Discounting Task [ Time Frame: Baseline ]
    Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.

  30. Delayed Reward Discounting Task [ Time Frame: 6-month end of treatment ]
    Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.

  31. Delayed Reward Discounting Task [ Time Frame: 12-month follow-up ]
    Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.

  32. NEURO-QOL [ Time Frame: Baseline ]
    self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured.

  33. NEURO-QOL [ Time Frame: 6-month end of treatment ]
    self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured.

  34. NEURO-QOL [ Time Frame: 12-month follow-up ]
    self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured.

  35. Brief Symptom Inventory [ Time Frame: Baseline ]
    Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress.

  36. Brief Symptom Inventory [ Time Frame: 6-month mid-treatment ]
    Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress.

  37. Brief Symptom Inventory [ Time Frame: 12-month end of treatment ]
    Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress.

  38. PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms [ Time Frame: Baseline ]
    Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression.

  39. PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms [ Time Frame: 6-month mid-treatment ]
    Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression.

  40. PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms [ Time Frame: 12-month follow-up ]
    Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression.

  41. PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms [ Time Frame: Baseline ]
    Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety.

  42. PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms [ Time Frame: 6-month end of treatment ]
    Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety.

  43. PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms [ Time Frame: 12-month follow-up ]
    Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety.

  44. Working Alliance Inventory [ Time Frame: Monthly during the six months of treatment. ]
    Quality of the therapeutic relationship. The WAI is scored on a 7-point Likert-type scale ranging from 1 (never) to 7 (always. Subscales can range from 12-83 and can be summed to obtain a total score-which range from 36-252. Higher scores reflect more positive ratings of the working alliance.

  45. Service Utilization Questionnaire [ Time Frame: Baseline ]
    Other services the youth may receive besides treatment conditions

  46. Service Utilization Questionnaire [ Time Frame: 3-month mid-treatment ]
    Other services the youth may receive besides treatment conditions

  47. Service Utilization Questionnaire [ Time Frame: 6-month end of treatment ]
    Other services the youth may receive besides treatment conditions

  48. Service Utilization Questionnaire [ Time Frame: 12-month follow-up ]
    Other services the youth may receive besides treatment conditions

  49. Parent Adolescent Relationship Questionnaire (PARQ) [ Time Frame: Baseline ]
    The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship.

  50. Parent Adolescent Relationship Questionnaire (PARQ) [ Time Frame: 6-month end of treatment ]
    The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship.

  51. Parent Adolescent Relationship Questionnaire (PARQ) [ Time Frame: 12-month follow-up ]
    The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. adolescents (ages 12-17) self-identifying as AA,
  2. BMI≥95th percentile for age and gender
  3. primary caregiver who is either overweight (BMI 25.0 to 29.9) or obese (BMI≥30) and willing to participate in treatment
  4. adolescent residing primarily with the primary caregiver within 30 miles of the MUSC, and 5) adolescent and caregiver obtain PA clearance from a health care provider (see Protection of Human Subjects).

Exclusion Criteria:

  1. obesity secondary to medication use for another medical condition (e.g., steroids, antipsychotics);
  2. secondary to a chronic condition (e.g., Down syndrome, Prader-Willi syndrome, Cushing's syndrome).

Exclusion criteria that apply to both adolescents and caregivers are:

  1. pregnancy,
  2. thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal
  3. serious cognitive impairment (e.g., inability to complete questionnaires)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974554


Contacts
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Contact: Phillippe B Cunningham, Ph.D. 843-876-1800 cunninpb@musc.edu

Locations
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United States, South Carolina
Division of Global and Community Health Recruiting
Charleston, South Carolina, United States, 29407
Contact: Colleen Halliday, Ph.D.    843-876-1800    hallidca@musc.edu   
Contact: Jennifer Smith-Powell, BA    843-876-1800    smithjl@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
Florida State University
Wayne State University
Investigators
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Principal Investigator: Phillippe B Cunningham, Ph.D. Medical University of South Carolina
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Responsible Party: Phillipe Cunningham, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04974554    
Other Study ID Numbers: 00106021
161HL155793-01 ( Other Grant/Funding Number: National Heart, Lung, and Blood Institute )
4R33HL155793-02 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the expiration of the study locked data files and variable and scale dictionaries will be made available to the NIH for archiving and sharing with other researchers, in accordance with NIH policies. The Contact PI (Cunningham) will ensure that all datasets provided will be prepared in accordance with NHLBI requirements for data repository and associated documentation for submission to the Biological Specimen and Data Repository Information Coordinating Center; NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies; and NHLBI Guidelines for Data Set Preparation. Results from the proposed study will be presented in required reports to NIH. Additionally, results will be presented to clinical researchers, clinical treatment organizations, and state and national legislative bodies as requested. Within one year of completion of the study and publication of the main study findings we will make available the datasets publicly.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phillipe Cunningham, Medical University of South Carolina:
obesity, African American adolescents
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases